PainPhase 4NCT00763685
Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery
A Phase 4 study testing etoricoxib in people with Pain, run by East Tallinn Central Hospital at 1 site in Estonia.
Trial summary
Primary Hypothesis: 1. The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pain
- What is being tested?
- etoricoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEstonia
- Study dates
- Jun 2010to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Type of gynaecologic surgery:
- diagnostic laparoscopy
- sterilization
- removal of ovarial cyst
- chromopertubation
- laparoscopic myomectomy
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- laparoscopic fenestration of ovaria
- laparoscopic adhesiolysis
- Age 18-50 years.
- Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II.
- Patients agreed to participate in the study and signed the informed consent.
Who cannot join
- ASA III or more
- Emergency surgery
- Major laparoscopic surgery i.e. hysterectomy
- Duration of surgery more than 90 minutes
- Chronic pain
- History of hypersensitivity to the active substance or to any of the excipients of study drug (Paracetamol or Etoricoxib)
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- Active peptic ulceration or active gastro-intestinal (GI) bleeding.
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
- Pregnancy and lactation
- Severe hepatic dysfunction (serum albumin < 25 g/l or Child-Pugh score ≥ 10).
- Estimated renal creatinine clearance < 30 mL/min.
- Children and adolescents under 16 years of age.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA II-IV).
- Patients with hypertension whose blood pressure has not been adequately controlled.
- Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, unstable angina.
- Patient has undergone coronary artery bypass graft surgery, angioplasty, or had myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
- History of drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind, Randomized, Placebo -Controlled Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery
Primary Hypothesis:
- The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain.
- Conditions
- Pain
- Being tested
- etoricoxib
- Keywords
- preoperative pain prophylaxis, postoperative pain
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoricoxibDrug
etoricoxib 120 mg, paracetamol 1 g
| Study group | Role | What they receive |
|---|---|---|
| etoricoxib 120 mg | Active comparator | active control Receives: Drug: etoricoxib |
| 2 | Placebo comparator | Placebo Receives: Drug: etoricoxib |
| 3 | Active comparator | Paracetamol 1 g and etoricoxib 120 mg Receives: Drug: etoricoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
Measured: 24 hours
Secondary outcomes (1)
Vomiting
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tallinn Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Tiina Arumagi, East Tallinn Central Hospital
- Investigators
- Tiina Arumägi, MD, Principal investigator, East Tallinn Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763685
- Sponsor's protocol ID
- 35195
- Other IDs
- EUDRACT 2008-004098-17
- Status last verified
- Jan 2012
- First submitted
- 30 Sep 2008
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Placebo -Controlled Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00763685
- Acronym / sponsor ID
- 35195
- Conditions
- Pain
- Keywords
- preoperative pain prophylaxis, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- East Tallinn Central HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Hypothesis:
- The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etoricoxib 120 mg | Active comparator | Drug: etoricoxibactive control |
| 2 | Placebo comparator | Drug: etoricoxibPlacebo |
| 3 | Active comparator | Drug: etoricoxibParacetamol 1 g and etoricoxib 120 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Type of gynaecologic surgery:
- Age 18-50 years.
- Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II.
- Patients agreed to participate in the study and signed the informed consent.
Key exclusion criteria (18 listed)
- ASA III or more
- Emergency surgery
- Major laparoscopic surgery i.e. hysterectomy
- Duration of surgery more than 90 minutes
- Chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etoricoxibetoricoxib 120 mg, paracetamol 1 g | Drug | 2, 3, etoricoxib 120 mg |
Primary outcome
Pain scale
Time frame: 24 hours
1 secondary outcome
Vomiting
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiina Arumägi, MD principal investigator
East Tallinn Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etoricoxib in people with Pain, run by East Tallinn Central Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.